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Alba Bioscience Limited SENIOR REGULATORY AFFAIRS OFFICER Competitive Salary/package

rosalyn-petersen
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Alba Bioscience Limited SENIOR REGULATORY AFFAIRS OFFICER Competitive Salary/package

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  1. The Senior Regulatory Affairs Officer must provide expert advice to Alba Bioscience Staff and maintain a specialist knowledge of regulatory affairs as applied to the manufacture of diagnostic devices, as the role requires liaising with regulatory agencies and external customers/distributors to provide information to support regulatory processes, to confirm compliance issues and advise as appropriate. A relevant degree and/or relevant work experience in a regulatory affairs environment is required. The successful candidate must have good organisational skills and be proficient with the use of core IT packages i.e. MS Office. Our benefits package includes competitive salary, bonus and pension scheme. To apply for this position, please email your current CV and covering letter to HR@albabioscience.co.ukquoting Reference (SRA1.1) Alternatively, Please post your current CV and covering letter to HR Department, Alba Bioscience Limited, 21 Ellen’s Glen Road, Edinburgh, EH17 7QT Closing date is 20 January 2012 Alba Bioscience will try to contact all applicants to inform them of the progress of their application. However, if you have not heard from us by 3 February 2012, you should assume that your application has not been successful. Alba Bioscience Limited SENIOR REGULATORY AFFAIRS OFFICER Competitive Salary/package Alba Bioscience Limited is a well-established bio-manufacturing organisation, with an internationally recognised product portfolio. The product range includes in vitro diagnostics for immunohaematology, immunology and haematology. Many products incorporate polyclonal antisera or monoclonal antibodies. The organisation offers contract services to the bioscience industry and currently manufactures products for major global players in the Life Sciences sectors. Development and manufacturing capabilities include pilot and large-scale mammalian cell culture, polyclonal antibody production, product formulation, liquid fill and packaging. All manufacturing is carried out according to current Good Manufacturing Practice in facilities located at two sites in Edinburgh area. Applications are sought for the above vacancy within theQuality & Regulatory Affairs Department based at Ellen’s Glen Road, Edinburgh. The primary role of the Senior Regulatory Affairs Officer is to compile product information for the preparation of regulatory dossiers to support product licence applications and their maintenance for worldwide regulatory authorities in compliance with ISO9001 and ISO13485, the IVD Directive 98/79/EC, FDA 21 Code of Federal Regulations (CFRs) and Canadian Medical Device Regulations (CMDR), Part 1.

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